(51 days)
The LINQ II ICM is an insertable automatically activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases:
· Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
· Patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia
The LINO II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachvarrhythmia. bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually record symptoms. In order to manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event. LINQ II ICM includes the following medical accessories: LINQ Tool Kit Model LNQ22TK, Patient Assistant Model PA97000, Reveal LINQ™ Mobile Manager Model MSW002 with patient connector Model 24967, Device Command Library Model 2692, Instrument Command Library Model 2691, and the Zelda (AccuRhythm) AI ECG Classification System Models ZA400, ZA410, and ZA420.
This document describes the 510(k) premarket notification for the LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22, which is being cleared for expanded indications for use. The submission focuses on expanding the existing indications to include the pediatric patient population and expanding MRI conditions for use.
Here's the information extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a specific table in the typical format of acceptance criteria with corresponding performance metrics for the device itself as a diagnostic tool. Instead, the "acceptance criteria" discussed are related to design validation and regulatory compliance for the expanded indications.
| Acceptance Criteria Category | Reported Device Performance/Compliance |
|---|---|
| Design Requirements (General) | Met design requirements |
| Safety and Effectiveness (Pediatric Use) | Assessed through retrospective clinical evaluation of published literature, post-market surveillance data, and studies. Concluded to be safe and effective. |
| MRI Conditions for Use | MRI bench testing for Low Field MRI test conditions and protocols demonstrated the product operated as expected ("Pass" status for all electrical testing). |
| Risk Management | Risk management activities performed, concluding that proposed labeling changes did not raise new safety or effectiveness issues. |
| Substantial Equivalence | Concluded to be substantially equivalent to the predicate LINQ II ICM (K200795) based on comparisons of indications for use, operating principle, device technology and functionality, and safety. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes a retrospective clinical evaluation.
- Sample Size: Not explicitly stated as a numerical sample size. It refers to an evaluation of "published literature, post-market surveillance data, and studies," suggesting a review of existing data rather than collection of new patient data for a specific test set.
- Data Provenance: Retrospective, derived from "published literature, post-market surveillance data, and studies." No specific country of origin is mentioned, but post-market surveillance data would likely span various regions where the device was previously marketed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The study was a retrospective clinical evaluation of existing data (published literature, post-market surveillance, and studies) to assess safety and effectiveness in the pediatric population for expanded indications. It did not involve establishing a new ground truth for a test set through expert adjudication of individual cases.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this was a retrospective review of existing data, not a study involving expert adjudication of a new test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. The document does not mention an MRMC comparative effectiveness study where human readers improve with or without AI assistance. The submission is for an expanded indication for an existing device, not a new AI-assisted diagnostic tool comparison.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
While the LINQ II ICM includes the "Zelda (AccuRhythm) AI ECG Classification System," this submission focuses on the expanded indications for use of the overall device (LINQ II ICM) for pediatric patients and MRI conditions. It does not provide details on standalone performance studies specifically for the AI component within this context. The core device functions to automatically detect arrhythmias, but the focus of this particular 510(k) is the hardware's expanded use.
7. The Type of Ground Truth Used:
For the clinical evaluation: The "ground truth" for assessing safety and effectiveness in the pediatric population was based on existing published literature, post-market surveillance data, and previous studies. This implies that clinical outcomes and established diagnostic criteria within those existing data sources served as the basis for evaluation.
8. The Sample Size for the Training Set:
Not applicable. This submission concerns the expansion of indications for an existing device, not the development or training of a new algorithm. If the "Zelda (AccuRhythm) AI ECG Classification System" was trained, information about its training set is not provided in this document as it pertains to the overall device's market clearance.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this submission does not detail the training of a new algorithm.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.